Effects of a Whole Body Vibration Training in Patients After Lung Transplantation

NCT ID: NCT01480960

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-12-31

Brief Summary

Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients following lung transplantation. Exercise training has been shown to be a cornerstone of an inpatient rehabilitation program to reduce muscle dysfunction and improve exercise performance. In our study we will investigate the benefit of a whole body vibration training in addition to a standard pulmonary rehabilitation program that includes endurance and strength training. We will include a total of 140 patients (70 patients < 1 year after lung Transplantation and 70 patients > 1 year after lung Transplantation). Our hypothesis is that an addtitional whole body vibration training produces a greater benefit to exercise capacity in lung transplantat patients (LTx).

Conditions

Patients Following Lung Transplantation (Single and Double)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Whole body vibration training

Whole body vibration training in addition to pulmonary rehabilitation

Group Type: ACTIVE_COMPARATOR

Pulmonary rehabilitation + whole body vibration training

Intervention Type: OTHER

standard inpatient rehabilitation program including endurance and strength plus squats on a vibration plate for 4x2 minutes, 3 times per week

No whole body vibration training

Pulmonary rehabilitation without whole body vibration training

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pulmonary rehabilitation + whole body vibration training

standard inpatient rehabilitation program including endurance and strength plus squats on a vibration plate for 4x2 minutes, 3 times per week

Intervention Type: OTHER

Other Intervention Names

Galileo training

Eligibility Criteria

Inclusion Criteria

• participation in an inpatient rehabilitation program
• double or single lung transplantation due to chronic obstructive pulmonary disease, Alpha-1-antitrypsine deficiency, interstitial lung disease

Exclusion Criteria

• severe exacerbation in the last 4 weeks with the necessity of delivering antibiotics/ corticosteroids
• non-compliance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role: lead

Responsible Party

Klaus Kenn

Dr. med. Klaus Kenn, Head physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Schön Klinik Berchtesgadener Land

Schönau am Königssee, , Germany

Countries

Germany

References

Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.

Reference Type: DERIVED

PMID: 34282853 (View on PubMed)

Other Identifiers

LTX2011

Identifier Type: -

Identifier Source: org_study_id